In Vitro Diagnostic Directive (98/79/EC)

What is the In Vitro Devices Directive?

The In Vitro Diagnostic (IVD) Medical Devices Directive introduced for the first time common regulatory requirements within the European Economic Area dealing specifically with the safety, quality and performance of in vitro diagnostic medical devices (IVDs).

This brings them into line with other medical devices. In essence, the Directive aims to make sure that IVDs are safe for use and meets the performance levels specified by their manufacturer.

What does the Directive cover?

This directive is relevant to you if you put IVD medical devices on the market in the European Economic Area whether they are designed and/or manufactured within or outside the European Economic Area.

LRQA services

Under the medical devices directive, LRQA is designated as a notified body for IVD medical devices using the quality system conformity routes laid out in Annexes III section 6, IV & VII

Certification

LRQA is able to perform product conformity assessment and certification activities against the directive such as:

  • Auditing
  • Design dossier - conducting design dossier examinations of Annex II List A devices
  • Verification - verifying that your technical documentation meets the requirements of the directive and is implemented within the system
  • Verification - carrying out verification of manufactured batches of defined high risk IVDs
  • Continued surveillance.